Trials Sponsors Conditions Drugs Pricing

Conditions

Clinically Significant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing csPCa
The primary outcome is to investigate a plasma-exosome RNA panel in diagnosing clinically significant prostate cancer (csPCa) and evaluate its sensitivity and specificity in diagnosing csPCa. Descriptive statistics were calculated and presented as the frequency (percentage) for categorical variables, the mean (standard deviation) for continuous variables with a normal distribution, and the median (quartile) for continuous variables with a skewed distribution. Two-sample t-tests were used to assess continuous variables with a normal distribution, and the Wilcoxon signed-rank test was used to assess continuous variables with a skewed distribution. The Mann-Whitney U test was used to compare means from two samples. The correlation between two samples was analyzed by Spearman's ρ test. The receiver operating characteristic (ROC) curve was used to determine the cutoff value of exo-RNA panel for diagnosing patients with csPCa.
The time of prostate biopsy

Secondary Outcomes (1)

Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa and its comparison with other imaging methods or blood tests
The time of prostate biopsy

Study Arms (1)

Study Cohort

The experimental arm receiving diagnosis from serum RNA combination

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The men with suspected prostate cancer

You may qualify if:

Blood prostate-specific antigen PSA\>4ng/dl;

Sponsors & Collaborators

Yan'an University Affiliated Hospital
Othercollaborator
Qinghai University
Othercollaborator
Weinan Central Hospital

Study Sites (10)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Qiang Zhang, MD.CONTACT+1 312 503 2891 q-zhang2@northwestern.edu

Qiang Zhang, MD.PRINCIPAL INVESTIGATOR

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

RECRUITING

CONTACT+86 0931 8625200

Study Officials

Weijun Qin, MD.
Xijing Hospital
STUDY CHAIR

Central Study Contacts

Jianhua Jiao, MD.

CONTACT

+86 029 84771062 1531769428@qq.com

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 25, 2026

Study Start

March 12, 2021

Actual (reported)

Primary Completion

December 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Plasma exoRNA-Based Liquid Biopsy to Diagnose Clinically Significant Prostate Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Study Cohort

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Study Cohort

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations